open-label study to assess immunogenicity and safety of a vaccine enhancement patch when administered with 2 doses of h5n1 vaccine

Conditions: Healthy

Summary: groups 1 to 3 will receive two vaccinations on day 0 and day 21. group 1 will receive 3.8µg a/h5n1 antigen formulated with as03 adjuvant, administered by im injection. group 2 will receive 15µg a/h5n1 by im alone. group 3 will also receive 15µg a/h5n1 antigen administered im but followed by the topical application of a vep at the vaccination site. group 4 will receive a single vaccination on day 0 of 30µg a/h5n1antigen by im, followed by application of a vep at the vaccination site. the vep (vaccine enhancement patch) contains 50 mcg lt (heat-labile enterotoxin of e. coli)


Eligibility criteria:
inclusion criteria: * healthy adult males or females 18-49 years of age (inclusive) * signed informed consent * women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and at all in-clinic visits with understanding to not become pregnant over the duration of the study. exclusion criteria: * clinically significant laboratory abnormalities at screening * abnormalities at physical examination * known allergies to any component of the a/h5n1 antigen * known egg protein allergy * known allergies to adhesives * known coagulation disorders * use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period * participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period * donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period * received or planned receipt of seasonal influenza vaccine during the study period * received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination * planned receipt of any licensed vaccine during the first 42 days on study * previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant * previous or planned vaccination with pandemic vaccine against a/h5n1 or previous proven contact with a/h5n1 wild type virus * ever received investigational enterotoxigenic e. coli lt, or lt (r192g) or nasalflu, berna biotech, ltd. ever received cholera toxin or vaccine * recent or regular use of oral, topical or injected steroid medications within 30 days prior to vaccination or planned use during the study period. * use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination or planned use during the study period * comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, and end-stage renal disease, as determined by the investigator * positive serology for hiv-1, hiv-2, hbsag, or hcv * history of severe atopy * medical history of acute or chronic skin disease at vaccination area * active skin allergy * signs of acute skin infection, sunburn or skin abnormalities at the vaccination area including fungal infections, severe acne, active contact dermatitis, or a history of keloid formation * hirsute at vaccination area * artificial tanning over the duration of the study including the screening period * visible tattoos or marks at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site * fever greater than or equal to 38.0°c at the time of planned vaccination * suspicion of or recent history of alcohol or substance abuse * women who are pregnant or breastfeeding * acute illness at screening or at the time of planned vaccination * ever had a serious reaction to prior influenza vaccination * developed a neurological disorder following a previous influenza vaccination or have any acute and evolving neurological disorder * employee of the investigational site or sponsor * history of employment in bird or poultry industries or considerable exposure to birds

Keywords: immunogenicity and safety